A Multicenter Study of RUS NE

NCT06868186 — Not applicable, Recruiting, 204 participants, Hutom Corp

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A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy

RegistryNCT06868186
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment204 (Estimated)
SponsorHutom Corp (Industry); collaborators: Asan Medical Center, Seoul National University Hospital, Samsung Medical Center, Chonnam National University Hospital, Kyungpook National University Hospital, Severance Hospital
ConditionsRenal Tumors
InterventionsRUS NE (Device)
Datesstart 2025-04-29, primary completion 2025-08-29, completion 2026-04-30 (estimated), first posted 2025-03-10, last updated 2025-09-11
Locations4 sites in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Renal Tumors All trials of RUS NE

-Summary

This sponsor-initiated, randomized controlled clinical trial aims to demonstrate the clinical efficacy of RUS NE Surgical Navigation System in patients undergoing robotic-assisted partial nephrectomy. The trial will compare the experimental group (n=102) using RUS NE with a control group (n=102), aiming to show an 10% reduction in operation time. The study will involve 6 medical centers in South Korea in patient recruitment and evaluate the clinical efficacy and feasibility of the software, which has been shown to be reliable in previous studies.

* Investigational Medical Device: RUS NE (Endoscopic Imaging Treatment Planning Software)
* Clinical Trial duration: 24 months from IRB approval -Target number of subjects: Total of 204 participants

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+Detailed description

After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.

+Arms and interventions

ArmTypeInterventionsDescription
Experimental GroupExperimentalDevice: RUS NEExperimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE.
Control armNo interventionExperimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE.
  • RUS NE (Device): The RUS NE is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the intra-abdominal surgical environments, allowing for the visualization of tumor, vascular structures and intra-abdominal organs during the surgical planning process and the operation. RUS NE utilizes preoperative CT images of the patients to segment tumor, organs, and blood vessels and reconstructs them into a 3D model. Although there is no direct intervention on the patient, the surgeon uses RUS NE as a surgical navigation tool to simulate the surgery before performing the actual procedure.

+Outcome measures

Primary outcomes

  • Operative time [The operative day (operative day ± 5 days)]: The duration of time between starting a surgical incision to the last sutures of the operation.

Secondary outcomes

  • Tumor and vessel identification time [The operative day (operative day ± 5 days)]: The duration of time between starting manipulation of the surgeon console to the finishing dissection of the hilum and perinephric fat
  • Resection volume [From the postoperative 1week to the postoperative 5 weeks]: Calculated from the 3-dimensional lengths from the resected renal specimen using ellipsoid formula (π/6XYZ)
  • Postoperative complications [From the postoperative 8 weeks to the postoperative 16 weeks]: Incidence of postoperative complications occurred within 4 weeks after the operation. The complications include urine leak, acute kidney injury, renal hemorrhage, fluid collection, abscess, and pulmonary or cardiac complications.

+Eligibility

Sex: All, ages: 19 Years to 80 Years

Inclusion Criteria:

* Individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy
* The diameter of renal tumor is 7cm or below
* Individuals aged between 19 and 80
* Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form

Exclusion Criteria:

* Individuals with solitary kidney or horseshoe kidney
* Individuals undergo bilateral nephrectomy
* Individuals undergo operation other than partial nephrecotmy
* Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes
* Individuals with severe chronic kidney disease (eGFR < 45, calculated with EPI-CKI equation)
* Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI
* Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study
* Individuals who were participated in other clinical study within 4 weeks of screening
* Individuals who are thought to be inappropriate to participate to the clinical trial by the investigators

+Locations (4)

FacilityCityCountryStatus
Chonnam National University HospitalKwangju, Jeollanam-doSouth KoreaRecruiting
Asan Medical CenterSeoulSouth KoreaRecruiting
Samsung Medical CenterSeoulSouth KoreaRecruiting
Severance HospitalSeoulSouth KoreaRecruiting

+Publications

  • Results publication: Lee S, Lee HY, Song C. Assessment of Feasibility and Outcomes of RUS Surgical Navigation System During Robot-Assisted Partial Nephrectomy for Small Renal Masses. Int J Urol. 2025 May;32(5):576-583. doi: 10.1111/iju.70014. Epub 2025 Feb 13. PMID 39945060

+Investigators